A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 364
- 试验地点
- 2
- 主要终点
- Urinary tract infections
研究概览
简要总结
Cystoscopy is a commonly performed procedure after gynecologic surgery, however, its use may increase patients' risk for acquiring urinary tract infections due to urinary tract instrumentation entry and reentry of the lower urinary tract with the cystoscope and foley catheter. Use of a novel multi-channel transurethral bladder catheter that allows for cystoscopy through a specialized port will permit cystoscopy to be performed without catheter removal. This may allow for intraoperative detection of urinary tract injuries with a reduction in both urethral manipulation and hospital-associated urinary tract infections. Other potential benefits may include a shorter procedure time and ease of use for providers.
详细描述
A cystoscopy is a procedure that inserts a thin tube with a light and camera through the urethra, so that the inside of the bladder can be checked for injuries. Current guidelines recommend that this is done after a hysterectomy. Normally, doing a cystoscopy requires that a patient's foley catheter (a tube inserted through the urethra and into the bladder to drain urine) gets removed and then replaced. This can potentially lead to a urinary tract infection (UTI).
CystoSureTM is a silicone device that was developed by surgeons to enable easy and standardized cystoscopy. The design of the CystoSureTM catheter has separate channels for draining the bladder and performing cystoscopy, so doctors can perform a cystoscopy without removing the catheter (which can, as described above, potentially lead to a UTI). In this study, investigators want to examine whether using a CystoSureTM catheter instead of a standard foley catheter could therefore lead to a reduced number of UTIs in hysterectomy patients. CystoSureTM is cleared by the FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18-90
- •Undergoing hysterectomy with or without concomitant procedures
排除标准
- •Known history of urinary tract anomaly (i.e. urethral diverticulum, ureteral duplication, ectopic ureter)
- •≥3 UTIs in past 6 months
- •Immunosuppressed patients
- •Premeditated urologic procedure during hysterectomy surgery
结局指标
主要结局
Urinary tract infections
时间窗: Up to 4 weeks after surgery
Rate of urinary tract infections (within 4 weeks of surgery) in patients undergoing cystoscopy with the novel urinary access system (CystoSureTM) versus rigid cystoscopy at the time of hysterectomy.
次要结局
- Detection of urinary tract injuries(At the time of surgery)
- Device feasibility(At the time of surgery)
- Surgeon satisfaction(After the first and last patient enrolled by each surgeon, through study completion (which is estimated to be up to 24 months after enrollment begins).)
研究者
charbel salamon
Principal Investigator; Director, Urogynecology
Atlantic Health System